Public trial
RBR-4xbmk94 Laser Varicose Vein Surgery associated with Foam treatment of Varicose Veins
Date of registration: 10/07/2021 (mm/dd/yyyy)Last approval date : 10/07/2021 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Endovenous Laser treatment combined with Sclerosing Foam in treating Varicose Veins
pt-br
Cirurgia de Varizes a Laser associado ao tratamento com Espuma
es
Endovenous Laser treatment combined with Sclerosing Foam in treating Varicose Veins
Trial identification
- UTN code:
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Public title:
en
Laser Varicose Vein Surgery associated with Foam treatment of Varicose Veins
pt-br
Cirurgia de Varizes a Laser associado ao tratamento de Varizes com Espuma
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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93060918.3.0000.5362
Issuing authority: Plataforma Brasil
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2.833.579
Issuing authority: Comitê de Ética em Pesquisa do Hospital Municipal São José - Joinville
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93060918.3.0000.5362
Sponsors
- Primary sponsor: Universidade Federal de Santa Catarina
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Secondary sponsor:
- Institution: Hospital Municipal São José
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Supporting source:
- Institution: Fabricio Duarte
Health conditions
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Health conditions:
en
Great saphenous vein insufficiency; Varicose veins
pt-br
Insuficiência da veia safena magna; Varizes
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General descriptors for health conditions:
en
I83 Varicose veins of lower extremities
pt-br
I83 Varizes dos membros inferiores
en
C14.907.927 Varicose Veins
pt-br
C14.907.927 Varizes
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Specific descriptors:
en
I83.9 Varicose veins of lower extremities without ulcer or inflammation
pt-br
I83.9 Varizes dos membros inferiores sem úlcera ou inflamação
en
C14.907.927 Varicose Veins
pt-br
C14.907.927 Veias Varicosas
en
E02.319.805 Sclerotherapy
pt-br
E02.319.805 Escleroterapia
Interventions
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Interventions:
en
Control group: 30 Patients with varicose veins in the lower limbs, with total insufficiency of the great saphenous vein will be submitted to the treatment of the great saphenous vein with laser associated with the treatmento of their varicose veins through phlebectomies (surgery) Interventional group: 30 Patients with varicose veins in the lower limbs, with total insufficiency of the great saphenous vein will be submitted to the treatment of the great saphenous vein with laser associated with 1% Polidocanol foam , associated with the treatment of their his varicose veins through phlebectomies (surgery)
pt-br
Grupo controle: 30 pacientes portadores de varizes nos membros inferiores, com insuficiência total da veia safena magna serão submetidos ao tratamento da veia safena magna com laser associado ao tratamento de suas varizes através de flebectomias (retirada cirúrgica) Grupo intervenção: 30 pacientes portadores de varizes nos membros inferiores, com insuficiência total da veia safena magna serão submetidos ao tratamento da veia safena magna com laser associado a espuma de Polidocanol 1%, associado ao tratamento de suas varizes de flebectomias. (retirada cirúrgica)
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Descriptors:
en
E02.319.805 Sclerotherapy
pt-br
E02.319.805 Escleroterapia
en
E07.632.490 Lasers
pt-br
E07.632.490 Lasers
en
C14.907.927 Varicose Veins
pt-br
C14.907.927 Varizes
en
E04.100.814 Vascular Surgical Procedures
pt-br
E04.100.814 Procedimentos Cirúrgicos Vasculares
Recruitment
- Study status: Recruitment completed
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Countries
- Brazil
- Date first enrollment: 08/30/2018 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 60 - 18 Y 0 -
Inclusion criteria:
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Patients older thant 18 years old, with varicose veins in the lower limbs with total insufficiency of the great saphenous vein and who agree to participate in the study and sign the consent form.
pt-br
Pacientes maiores de 18 anos, portadores de varizes nos membros inferiores com insuficiência total da veia safena magna e que concordarem participar do estudo e assinarem o termo de consentimento
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Exclusion criteria:
en
Patients with previous deep vein thrombosis, patients with reflux in the deep venous system, patients with small saphenous vein insufficiency, patients with thrombophilia or other coagulation disorders, patients with allergies to Polidocanol or Lidocaine, patients with active cancer, patients with of severe peripheral arterial disease, pregnant or lactating patients, patients with severe diseases and patients with symptomatic patent foramen ovale
pt-br
Paciente com trombose venosa profunda prévia, pacientes com refluxo no sistema venoso profundo, pacientes com insuficiência da veia safena parva, pacientes portadores de trombofilia ou outros distúrbios da coagulação, pacientes com alergia ao Polidocanol ou Lidocaína, pacientes portadores de neoplasia em atividade, pacientes portadores de doença arterial periférica grave, pacientes gestantes ou lactantes, pacientes portadores de doenças graves e pacientes portadores de forame oval patente sintomático
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Treatment Parallel 2 Open Randomized-controlled 3
Outcomes
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Primary outcomes:
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It is expected to find a similar rate of great saphenous vein occlusion between the two different methods, one year after the procedure, performed through the echo-color-Doppler exam, based on the finding of a variation of less than 5% in the measurements after the intervention.
pt-br
Espera-se encontrar uma taxa de oclusão da veia safena magna semelhante entre os dois métodos, um ano após o procedimento, verificado através do exame eco-color-Doppler, a partir da constatação de uma variação inferior a 5% nas medições após a intervenção
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Secondary outcomes:
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To assess the specific quality of life for venous disease one year after the procedure by applying the Aberdeen questionnaire
pt-br
Avaliar a qualidade de vida específica para doença venosa após um ano do procedimento através da aplicação do questionário Aberdeen
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To verify the complications rate between the different groups within a year interval
pt-br
Verificar a taxa de complicações entre os diferentes grupos no período de um ano
Contacts
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Public contact
- Full name: Caroline Silveira
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- Address: Rua Professora Maria Flora Pausewang 108
- City: Florianopolis / Brazil
- Zip code: 88036-800
- Phone: +55 (48) 3721-9150
- Email: ppgcm@contato.ufsc.br
- Affiliation:
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Scientific contact
- Full name: Fabricio Duarte
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- Address: Rua Henrique Meyer 280
- City: Joinville / Brazil
- Zip code: 89201-480
- Phone: +55(47)996734567
- Email: fabriduarte@bol.com.br
- Affiliation:
- Full name: Getulio Rodrigues De Oliveira Filho
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- Address: Rua Professora Maria Flora Pausewang 108
- City: Florianopolis / Brazil
- Zip code: 88036-800
- Phone: +55(48)3721-9150
- Email: oliveirafilho@gmail.com
- Affiliation:
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Site contact
Additional links:
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